MAUDE Adverse Event Report: ALLERGAN (PRINGY) VOLIFT WITH LIDOCAINE; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 94201JR

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Cyst(s) (1800); Unspecified Infection (1930); Skin Irritation (2076)

Event Date 04/03/2018

Event Type  Injury  

Manufacturer Narrative

The events of "infection", "cyst", "hard", "edema", "erythema", "right side slightly hanging" and "soreness" are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.A review of the device history record has been initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.Device labeling addresses the reported event(s) as follows: precautions for use: as a matter of general principle, injection of a medical device is associated with a risk of infection.Standard precautions associated with injectable materials shall be followed.Undesirable effects: the patients must be informed that there are potential side effects associated with implantation of this product, which may occur immediately or may be delayed.These include, but are not limited to: inflammatory reactions (redness, oedema, erythema, etc.) which may be associated with itching and/or pain on pressure and/or paresthesia, occurring after the injection.These reactions may last for a week.In particular, it has to be noticed that injection in the mucous membrane may cause more oedema and bruising due to the specific physiology of theses tissues.Besides, a preventive anti-inflammatory treatment by a medical practitioner can be recommended.Induration or nodules at the injection site.Warnings: do not re-use.Sterility of this device cannot be guaranteed if the device is re-used.

Event Description

Healthcare professional (hcp) reported patient was injected with 1 ml of juvéderm® volift¿ with lidocaine in the nasolabial folds.Injection sites were treated with alcohol (85%) before injection.The next day, patient presented with "a 2x3 cm hard, taught cyst, with surrounding edema, causing the corner of the mouth to droop" in the right nlf.Hcp also observed erythema, some soreness, and indicated "right side slightly hanging".Hcp determined "this was not a drainable infection and [prescribed] dicillin tablets, 1 gr x 4 and benadryl 8 mg x 2".2 days after onset "soreness and erythema had decreased, while the cyst more well-defined and taught, but still assessed as undrainable." hcp administered "100 iu hyalase".Hcp later reviewed patient and noted "today the cyst is 1 x 2 cm and less taught and less sore, there is some slightly increasing declive edema".Hcp instructed patient to "continue 1 dicillin x 3 for 10 days." symptoms resolved 6 days after onset.

• Brand Name: VOLIFT WITH LIDOCAINE
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): ALLERGAN (PRINGY); route de promery; zone artisanale de pre-mairy; pringy 74370 ; FR 74370
• Manufacturer (Section G): ALLERGAN (PRINGY); route de promery; zone artisanale de pre-mairy; pringy 74370 ; FR 74370
• Manufacturer Contact: suzanne wojcik ; 301 w howard lane; suite 100; austin, TX 78753 ; 7372473605
• MDR Report Key: 7545438
• MDR Text Key: 109291992
• Report Number: 3005113652-2018-00713
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 94201JR
• Device Lot Number: V17LA70130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/02/2018
• Initial Date FDA Received: 05/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: ALCOHOL (85%) AND "AFSPRITNING" BEFORE INJECTION
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR